Usually, a textile piece for parietal repair is fastened to the anatomical zone for reinforcement by clips in order to guarantee durable fastening to human tissue, in particular given the mechanical stresses exerted by the abdominal muscles, internal organs, and other organs that might move the textile piece away from the position in which the practitioner implanted it.
Such clips are traumatizing in that postoperative pain is often observed, particularly when a nerve ending is pinched. In addition, suturing by means of clips is an operation that is lengthy and tedious.
To combat those drawbacks, surgical adhesives have been developed that are suitable for causing the textile piece to adhere to human tissue, where such adhesives are glues based on fibrin or on cyanoacrylate.
Fibrin adhesives are biological tissue adhesives derived from human plasma. Those adhesives contain the components required for the last step of coagulation and they are commonly used during surgery to prevent bleeding and to encourage the healing of wounds.
Fibrin adhesives are not ready for use since the formulation needs to be prepared in theater in order to avoid any risk of contamination. Such preparation is also complex and lengthy.
Fibrin adhesives have poor adhesive power in general, and particularly when compared with adhesives based on cyanoacrylate.
Cyanoacrylate adhesives have high adhesive power on human tissue but they give rise to necrosis thereof, or they may burn them by an exothermic reaction. In addition, such cyanoacrylate adhesives harden very quickly, thereby preventing the textile piece being repositioned by the practitioner over the zone for treatment. Finally, the biocompatibility of those adhesives has not been demonstrated. The exothermic hardening reaction that takes place in contact with human tissue gives off toxic substances.
Document FR 2 863 502 in the name of the Applicant describes a surgical implant comprising a textile and a biocompatible polymer, the polymer being hydrosoluble and suitable for causing the implant to adhere to human tissue under the combined action of a pressure force and water molecules. Amongst the polymers mentioned, there are in particular polyvinylpirrolidone (PVP) and carboxymethylcellulose (CMC), having adhesive properties that may optionally be adjusted by adding polyethylene glycol (PEG), and more particularly in a ratio of 64% by weight PVP and 36% by weight PEG.
Unfortunately, the textile implant described in FR 2 863 502 does not is give complete satisfaction. The Applicant has observed that in theater, when said textile implant is being put into place on human tissue, the adhesive responds to any contact as soon as its package has been opened, and thus even before it has been activated by the moist medium of the tissues. This gives rise to a significant loss of adhesive onto the practitioner's gloves and inside the package, and consequently to results that are degraded in terms both of durable fastening of the implant on tissue and of ease of repositioning. In practice, the quantity of adhesive that remains on the implant can be insufficient. Furthermore, when the textile implant is to be inserted by means of a trocar, with the implant being rolled up, the bio-adhesive composition is sticky even though it has not been activated by the moist medium of the tissues, so a fraction of the adhesive remains on both faces of the textile implant, which then runs the risk of adhering to the wall opposite from the zone to be reinforced.
Furthermore, it has been observed that the adhesive runs directly inside the packaging sachet as a result of the step of sterilizing the implant, in particular using ethylene oxide, during which step the temperature rises. Apart from the unattractive appearance of such streaking, it also gives rise to a lack of confidence with practitioners.
Following tests on animals, it has been found that a few days after implantation, the textile implant tends to collapse and then cease to be effective. Furthermore, since the adhesive power is not sufficient for fibrosis to have the time to develop and fasten the textile implant definitively, there is a tendency for the implant to move away from the position in which it was implanted by the practitioner.